MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752918
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that balance tip broke during cataract surgery (with intra ocular lens implantation).The surgery was completed by using a new tip.There was no patient harm (no serious injury).
Additional Manufacturer Narrative
One opened broken phaco tip without a wrench, wrapped in plastic wrap.Only top half of broken tip returned for the report.Sample was visually inspected and found to be nonconforming, phaco broken at aspiration bypass hole, breakage is very jagged on the 1 part of the broken piece that was returned.Wall thickness is even.Wear observed on threads, back of flange, and nut corners consistent with threading on handpiece.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo shows a broken part of phaco tip confirming the event.Videos show broken phaco tip removed from sleeve during surgery confirming the event.The complaint evaluation confirms the event.The root cause for the broken phaco tip cannot be determined from this evaluation.The phaco tip visual inspections do not show any manufacturing issues that would cause the event.The exact root cause for the broken phaco tip is unknown; therefore, specific action with regards to this complaint cannot be taken.An investigation has been completed and actions are presently being implemented to eliminate the broken phaco tip issue.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken phaco tip exhibited on the returned opened sample, are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19141909
• Report Number: 1644019-2024-00764
• Device Sequence Number: 7920697
• Product Code: LRO
• UDI-Device Identifier: 00380657529186
• UDI-Public: 00380657529186
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 8065752918
• Device Lot Number: 14V1E9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown